comparing effect of tracheostomy on day 2 and day 5 of injury in traumatic brain injury patients

The effect of very early tracheostomy versus early tracheostomy on weaning from mechanical ventilation in patient with severe traumatic brain injury- A Prospective randomized comparative study (VEET- TBI study) - VEET- TBI

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/089459

Enrollment

Registered

2025-06-24

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: S069- Unspecified intracranial injury

Interventions

Intervention1: Early tracheostomy: Tracheostomy on day 5 of ICU stay Control Intervention1: Very early tracheostomy: tracheostomy on Day 2 of ICU stay

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with isolated moderate to severe TBI (GCS 6-12) 2.Rotterdam score 3 and above 3.ASA IE, IIE, IIIE 4.Presentation to hospital within 24 hours of injury 5.Consent for participation in the study from legal heir

Exclusion criteria

Exclusion criteria: 1.Patients with hemoglobinopathies, deranged coagulation parameters. 2.Preoperative hemodynamically unstable patients requiring vasopressors / inotropes, polytrauma. 3.Pregnant patients 4.Patients with chronic liver disease, renal disease and decompensated heart failure 5.History of emergency tracheostomy 6. Anatomical deformity of the neck 7.Refusal to participate in the study 8. Severe respiratory distress with refractory hypoxemia and hypercapnia

Design outcomes

Primary

Measure	Time frame
Duration taken to wean off from mechanical ventilator in terms of number of daysTimepoint: From the day of intubation to the day patient is free from ventilator.	—

Secondary

Measure	Time frame
1. Incidence of VAP (ventilator associated pneumonia) 2.Incidence of tracheostomy related complication 3.Amount of sedation required after tracheostomy till 3 days from tracheostomy 4.Complications in ICU such as deep vein thrombosis, Decubitus ulcer, sepsis, etc 5.Length of ICU stay. 6.Length of hospital stay. 7.GOSE at discharge and at1 month. 8.In hospital mortality and mortality at 1 monthTimepoint: From the day of tracheostomy to 1 month from the day of discharge.	—

Measure

Time frame

1. Incidence of VAP (ventilator associated pneumonia) 2.Incidence of tracheostomy related complication 3.Amount of sedation required after tracheostomy till 3 days from tracheostomy 4.Complications in ICU such as deep vein thrombosis, Decubitus ulcer, sepsis, etc 5.Length of ICU stay. 6.Length of hospital stay. 7.GOSE at discharge and at1 month. 8.In hospital mortality and mortality at 1 monthTimepoint: From the day of tracheostomy to 1 month from the day of discharge.

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Countries

India

Contacts

Public ContactDr SHALVI MAHAJAN

Post Graduate Institute of Medical Education and Research

drshalvimahajan@gmail.com7087174849

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026